Heart failure & cardiomyopathiesCohort study
Effectiveness and safety of sodium-glucose cotransporter-2 inhibitor initiation in sacubitril-valsartan users with heart failure: a population-based cohort study
- prevalent new-user cohort study
- target trial emulation
- time-conditional propensity score matched
- population-based
- linkable administrative data
Authors' conclusion
This observational real-world evidence study supports effectiveness of SGLT2i among older sacubitril-valsartan users with heart failure, and suggests no increase in the safety outcomes studied, except genital infection.
Study context
- Population
- Sacubitril-valsartan users with heart failure aged ≥66 years in Ontario, Canada (October 2019 to June 2024)
- Participants
- 5,000 matched pairs
- Exposure
- SGLT2i initiators matched on time-conditional propensity scores to non-initiators
Main finding
As reported in the abstract
Composite of:
- Hospitalization for heart failure (HHF)
- All-cause mortality
Hazard ratio
0.71
95% CI 0.64–0.78
By group
SGLT2i initiators vs non-initiators
HR 0.71 (95% CI 0.64–0.78)
Observational data: associations, not effects.
Safety
| Outcome | SGLT2i initiators | non-initiators | HR (CI) | |
|---|---|---|---|---|
| Genital infection · higher risk with SGLT2i initiation | 1.8% | 0.7% | 2.36 (1.58–3.51) | |
| AKI, by diabetes status · among those with diabetes; lower AKI | 0.78 (0.66–0.94) | |||
| 0.20.5125Hazard ratio (log scale) |
| Outcome | HR (CI) |
|---|---|
| AKI, by diabetes status · among those without diabetes; CI as printed | 1.01 (0.66–0.94) |
- Acute kidney injury (AKI), by diabetes status: HR homogeneity: P = 0.035
Falls, hospitalization for hypotension, urinary tract infection (UTI)
- not associated with higher rates of falls, hospitalization for hypotension, or UTI
Diabetic ketoacidosis (with diabetes); hypoglycaemic events (without diabetes)
- Diabetic ketoacidosis uncommon among SGLT2i users with diabetes, as were hypoglycaemic events among SGLT2i users without diabetes
Original publication
Effectiveness and safety of sodium-glucose cotransporter-2 inhibitor initiation in sacubitril-valsartan users with heart failure: a population-based cohort study. Eur Heart J Cardiovasc Pharmacother. Published 7 May 2026. doi:10.1093/ehjcvp/pvag031
Summarised from the published abstract; every number is checked against it